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The expert advisers to the Food and Drug Administration were scheduled to meet Thursday and Friday to consider a petition that argues the over-the-counter medicines shouldn't be used in children 5 and younger. The meeting opens a week after drug makers pulled from sale oral cough and cold medicines for children under 2. The drug industry maintains the widely used medicines are safe and work but can lead to overdoses when misused in infants.
However the petitioners, including Baltimore city health officials, argue that the medicines not only don't work in children up to age 6 but that they can be dangerous as well.
The drugs -- which include some Dimetapp, Pediacare, Robitussin and Triaminic products
-- have never been tested in children. Drug makers instead have used extrapolated data from studies in adults.
While the focus of the petition and the FDA is on children under 6, the joint panel of experts will be asked if there's evidence that these drugs work in children up to age 12.
The FDA has not acted on the petition, saying it awaits a recommendation from outside experts.
[Associated Press]
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